Kornimate/medical-research-clean huggingface dataset:
acitretin or tazarotene gel and excimer laser for treatment of psoriasis

Conditions: Psoriasis

Summary: this is a randomized, double-blind study of excimer (308-nm uvb) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis. the primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm uvb) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% qd.

the hypothesis of this study is that excimer (308-nm uvb) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone. the primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm uvb) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% qd. the primary endpoint will be the comparison between the change in npf score of plaques treated with excimer laser and those treated with sham treatment. the secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg po or tazarotene gel 0.1% qd, and to evaluate adverse events related to combinations of the study treatments.

Eligibility criteria:
inclusion criteria: * must give written informed consent * must be at least 18 years old * must have been diagnosed with stable plaque type psoriasis covering between 1 and 5% bsa * npf-ps ≥8 (based additive scores averaged over all lesions for erythema, scale, and thickness range of score = 0-5) * no systemic or phototherapy in the 4 wks prior to entering the study * no topical therapy other than emollients (no corticosteroids, vitamin d analogs, vitamin a analogs) in the 2 wks prior to entering the study * women on tazarotene gel must not be pregnant nor planning to become pregnant during the study and must be on two forms of birth control * subjects known to not tolerate oral acitretin at 25 mg/day and women of child-bearing potential may be enrolled and treated with topical tazarotene gel 0.1% exclusion criteria: candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of enrollment: * unstable disease * only treatable sites are in intertriginous areas or on face * subjects unable to tolerate frequency of visits * npf-ps severity score \<8 additive score of erythema, scale, and thickness, averaged over all lesions * history of inability to tolerate topical tazarotene 0.1% gel and or acitretin 25 mg/day * women of childbearing potential are excluded from the actretin arm of the study.

Keywords: psoriasis excimer acitretin tazarotene
micronized purified flavonoid- fraction (mpff) in the management of radiation proctitis

Conditions: Proctitis Radiation

Summary: national and multi-center trial for medical therapy of chronic radiation proctitis inducing anorectal bleedings

radiation proctitis is an inflammation of rectal mucosa, a complication following radiation therapy for cancers of the prostate, cervix, uterus, bladder and other malignancies in the pelvic area. around 20 % of radiation patients develop radiation proctitis. there is a significant lack of trial treatments for radiation proctitis, even more, the studies often are small and single center designed or case series. in 2 recent reviews pointing out the management of radiation proctitis (2018 and 2016) a summary of current options in therapy according to current scientific knowledge is given. unfortunately, these studies are about interventional options with the serious risk of complication. only little data and lack of significance in smaller series on conservative strategies are given. the goal of the trial is to implement a specific medication in the management and every grade of radiation proctitis - concomitant to eventual need of mmpf is described with potent anti-inflammatory mucosal capacity reducing bleeding, pain and urgency symptoms in patients with hemorrhoidal and/or postoperative symptoms. by using a placebo instead of comparative oral medications (with low evidence) this study might illustrate clinical significance of expected results as well as information on the natural history of radiation proctitis. the goal of the study is to compare the number of necessary interventions required to stop bleeding in chronic radiation proctitis in patients receiving mmpf in comparison to patients in the control group receiving placebo within 12 months of medical treatment.

Eligibility criteria:
inclusion criteria: * signed informed consent form * male and female patients * age ≥ 18 years * patients with diagnosis of radiation proctitis with macroscopic bleeding * end of radiotherapy ≥ 3 month = 90 days ago exclusion criteria: * infectious proctitis * ulcerative proctitis (inflammatory bowel disease) * persons unable to understand the informed consent * persons, who are in dependent relationship with the study investigators or sponsor * pregnant or lactating women * participation in an interventional study
exercise intervention in breast cancer patients with treatment-induced arthralgia

Conditions: Breast Cancer; Arthralgia

Summary: this is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.


Eligibility criteria:
inclusion criteria: * post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month. * patients must complain of mild to moderate arthralgia. * ability to understand and sign informed consent. * patients meet criteria for low to moderate risk for moderate exercise based oon the acsm guidelines. exclusion criteria: * inability to comply with study requirements. * metastatic breast cancer. * patients with orthopedic or neuromuscular disorders that preclude participation in exercise. * rheumatoid arthritis. * history of mi, angina or congestive heart failure. * pregnant or lactating females. * patients that are high risk for moderate exercise based on acsm risk classification. * patients who exceed minimal physical activity recommendations from the us surgeon general's report: accumulation of 30 minutes or more of moderate physical activity on most days of the week. * morbidly obese with bmi ≥ 40
dietary adherence enhancement in peritoneal dialysis: balancewise-pd

Conditions: End-Stage Renal Disease

Summary: this randomized study will pilot test an intervention, based on self-efficacy theory and involving personal digital assistant (pda)-based dietary self-monitoring, to improve adherence to the peritoneal dialysis dietary regimen. 60 individuals, 21 years of age or older, who are on continuous ambulatory peritoneal dialysis or nightly cycler peritoneal dialysis, will be recruited to the study. participants will be randomized to one of 2 groups. group a will receive a 4-month active intervention of decreasing intensity over time delivered via mail, telephone, and during regularly scheduled dialysis clinic visits. group b will receive a 4-month attention control experience in which they receive reinforcement of standard dietary education. with this study the investigators will: 1. explore the impact of the intervention on dietary sodium intake, 2. explore the intervention on blood pressure, 3. explore the impact of the intervention on morning post dialysis weight (i.e. weight after conclusion of continuous cycling peritoneal dialysis (ccpd) or after long dwell for continuous ambulatory peritoneal dialysis (capd) patients, and 4. explore the feasibility and acceptability of the intervention


Eligibility criteria:
inclusion criteria: the investigators will recruit those individuals: * who are 18 years of age or older, * who are literate, community-dwelling adults, and * who have been receiving maintenance pd for at least 3 months. individuals on maintenance pd less than 3 months are excluded to allow for patients to adjust to the pd regimen, and for stabilization of nutritional status in the early weeks of dialysis (i.e. they may be considered for the study after 3 months of dialysis) exclusion criteria: excluded from the study will be individuals: * who are deemed by dialysis center staff to have a problem with cognitive function and to be chronically noncompliant to the dialysis regimen (e.g. misses multiple appointments and dialysis treatments), * those who cannot read or write, those who do not speak english, * those who plan to move out of the area or change dialysis centers within the next 5 months, * those with a terminal illness and life expectancy of less than 12 months, * those who are scheduled for a living donor transplant, * individuals who cannot see the pda screen or use the stylus to make selections from the pda screen, or * individuals who are living in a nursing home or personal care facility, who would have limited control over their dietary intake

Keywords: peritoneal dialysis diet sodium
prm-151 in the prevention of scarring following trabeculectomy

Conditions: Glaucoma

Summary: this study will assess the safety and tolerability of prm-151 administered as a subconjunctival injection and explore the effect of prm-151 on various correlates of the wound healing process that occurs in the eye after glaucoma filtration surgery.

glaucoma is a disease of the eye which affects the optic nerve (the nerve that sends signals from the eye to the brain) and is associated with visual field defects and potential blindness. the treatment of glaucoma involves lowering the pressure in the eye, which is often (but not always) elevated due to accumulation of fluid inside the eye that cannot drain away. in the operation called trabeculectomy (a type of filtration surgery), a small channel is created through the sclera (the white of the eye) to allow accumulated fluid to drain away. scarring may occur after surgery when, during healing, too much collagen (a type of protein) is deposited in the channel. this causes the channel to seal up and the pressure inside the eye to build up again. the study will be conducted in patients suffering from glaucoma who are due to undergo trabeculectomy. patients will be randomized to have either prm-151 or placebo.

Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential (woncbp) aged 18 years and older at screening. * diagnosis of chronic angle-closure glaucoma or open-angle glaucoma, phakic or pseudophakic, with visual field or optic disc changes characteristic of glaucoma. for pseudophakic glaucoma patients, the cataract surgery performed was with phacoemulsification and through a corneal incision. * suitable candidate for trabeculectomy in the study eye which the physician deems as medically necessary. exclusion criteria: * diagnosis of glaucoma other than chronic angle-closure glaucoma or open-angle glaucoma (ie., uveitic, traumatic or neovascular glaucoma). * any previous ocular surgeries in the study eye involving the upper conjunctiva and sclera. * history of laser surgeries in the study eye within 90 days before day 1. * presence or history of any disease that could affect wound healing. * any asymmetric abnormality of the anterior segment which requires additional intervention (surgery or medication). * any abnormality other than glaucoma in the study eye that could affect tonometry. * presence or history of uveitis within 10 years or any other ocular infection or inflammation within 14 days before day 1. * clear corneal phacoemulsification performed within 90 days before day 1.

Keywords: glaucoma, trabeculectomy
personalised prediction of disease course in ulcerative colitis using multimodal machine learning - part of the presager project

Conditions: Ulcerative Colitis

Summary: in patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8. secondary endpoints: * an artificial intelligence model's precision in predicting a new flare within 2 and 3 years * an artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of uc for at least 1 year * relapse due to uc. * first endoscopic and histological evaluation of the flare exclusion criteria * well-founded doubt that the flare is due to other than the patients uc
trial assessing roux-en-y anastomosis of the pancreatic stump to prevent pancreatic fistula following distal pancreatectomy

Conditions: Pancreatic Cancer; Pancreatic Cystic Lesions; Chronic Pancreatitis; Pancreatic Neuroendocrine Tumors; Pancreatic Pseudocysts

Summary: the objective is to clarify roux-en-y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.

the objective of this study was to clarify roux-en-y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (dp) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail. various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after dp. however, appropriate surgical stump closure after dp is still controversial. the primary endpoint in this trial was defined as the incidence of pancreatic fistula .

Eligibility criteria:
inclusion criteria: 1. disease of pancreatic body and tail 2. ps (ecog performance status scale):0-1 3. age: 20 years or older 4. distant metastases are not diagnosed preoperatively. eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis. 5. adequate organ functions filled the following criteria within two weeks from enrollment: 1.white blood cell： \>3,500/mm3 or \ 2,000/mm3 3.platelet\>100,000/mm3 4.hemoglobin \> 9.0g/dl 5.total bilirubin \<2.0mg/dl 6.ast and alt\<150iu/l 7.creatinine \<1.5mg/dl 6)patients who can provide written informed consent exclusion criteria: 1. patients with severe liver cirrhosis or active hepatitis 2. patients with respiratory illness that requires oxygen administration 3. .patients with chronic renal failure requiring dialysis 4. patients with active duplicative malignant disease affecting adverse event 5. others, patients who are unfit for the study as determined by the attending physician

Keywords: distal pancreatectomy pancreatic fistula pancreaticojejunostomy roux-en-y anastomosis stapling closure
the feasibility of a brief attention training technique in improving behaviour and attention in children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study aims to investigate the application of the attention training technique in children with adhd aged 7-11 years old. the research aims to investigate both the feasibility of this technique in this population as well as whether it can improve symptoms, behaviour and executive functioning.

attention deficit hyperactivity disorder (adhd) is a neurobehavioural disorder characterised by core symptoms of hyperactivity, impulsivity and inattention. its prevalence ranges between 3-9% of school-aged children, making it one of the most common presentations in child and adolescent mental health services. in the last 10 years, research into the effectiveness of attention training as an intervention for children with adhd has been increasing. this has tended to follow assumptions that children with the disorder either lack skills in focusing and maintaining their attention and/or have neurological deficits in areas responsible for attention functions. results have been encouraging, with study participants demonstrating improvements in symptoms and behaviour following a course of attention training. however, the method and length of training has varied across studies. this study aims to investigate a treatment called the attention training technique (att) that approaches attention difficulties in this disorder from a different perspective. instead of viewing inattention as a result of structural or skills deficits, it posits that children with adhd have these skills, but are perhaps unaware of the flexibility and control they have over them. this treatment aims to increase this awareness and subsequently improve ratings of attention, behaviour and other areas of executive functioning.

Eligibility criteria:
inclusion criteria: * children with a formal diagnosis of adhd as given by a psychiatrist or community paediatrician * children between the ages of 7 and 11. this age group was selected as previous research on attention training in this population has used this age group * children who are currently on a waiting list at a child and adolescent mental health service (camhs) or a child psychology service, or being seen by a camhs or psychology service for medication review only * children who speak fluent english which will ensure they are able to comprehend the tasks instructions adequately. exclusion criteria: * children who are not stabilised on stimulant medication and/or willing to maintain their medication type/dose * children with a major neurological illness or acquired central nervous system injury * children who at the point of referral have a co-existing diagnosis of an autistic spectrum disorder * children who are currently in receipt of another non-pharmacological intervention for adhd or who are currently taking part in another research trial
transarterial chemoembolization (tace) plus sorafenib versus tace for advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: the aim of this study is to compare the outcomes of transarterial chemoembolization (tace) followed by sorafenib with tace alone in patients with advanced hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * male or female patients \> 18 years and \<=70 years of age. * at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence. * tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis. * criteria of liver function: child a-b level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. * no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal. * hb ≥90g/l,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³ * patients who can understand this trial and have signed information consent exclusion criteria: * patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer. * patients with other diseases which may affect the treatment mentioned. * patients with a medical history of other malignant tumors. * subjects participating in other clinical trials. * liver function:child c. * no pathological evidence of hepatocellular carcinoma.

Keywords: carcinoma, hepatocellular chemoembolization, therapeutic sorafenib
diagnostic performance of coronary calcification detection on ct scan

Conditions: Acute Coronary Syndrome

Summary: thoracic pain is one of the most frequent reasons for consulting the emergency room. chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management. the investigators seek to evaluate whether a diagnostic strategy based on a thoracic ct scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * patient admitted to the emergency room of the nouvel hôpital civil in strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain \<30min or atypical symptoms but non-eliminable cardiac origin. * patient with an initial assessment within the norms (ecg not modified, first troponin negative) and having performed a chest ct scan * patient who has not expressed his opposition to the reuse of his data for scientific research purposes. exclusion criteria: - patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes

Keywords: thoracic pain acute coronary event ct scan thoracic scan coronary calcifications acute coronary syndrome
project valor: veteran stress and wellbeing

Conditions: Alcohol Use Disorder; Depression

Summary: this study will examine the efficacy of an internet-based brief intervention designed to reduce risky behavior veterans as the move into their second year post-army. up to 350 veterans drawn from the network study (dept of defense; award number: w81xwh1920001) will be recruited with the intention of drawing a final sample of 300. study participants will be randomly assigned to either the intervention or the control group, stratified by age and gender.

the combination of alcohol use and negative emotional states is a particularly toxic combination for suicide risk. the current study examines changes in alcohol/drug use/misuse and depression as veterans transition further into their post-army environment and offers a personalized internet-based brief intervention intended to prevent/reduce alcohol misuse and depression in this population. the study's objectives are to empirically quantify the form of changes that occur with respect to alcohol use and depression as veterans move into their second year post-army; to identify stable individual risk factors (e.g., personality, military experiences) and dynamic risk factors (e.g., changes in stressors and normative contexts over time) that may be associated with differential temporal patterns of suicide-related behavior (i.e., alcohol use/misuse) and cognition (i.e., depression); and lastly, to determine whether a simple, internet-delivered brief intervention shown can reduce risky behavior in the veteran population.

Eligibility criteria:
inclusion criteria: * is us army veteran who participated in the network study (dept of defense; award number: w81xwh1920001) * seeks/engages in civilian employment * lives in us exclusion criteria: * retired with no plans to seek civilian employment * living outside of the us * separated from the national guard or reserves

Keywords: alcohol-related disorders anxiety alcoholism self medication stress disorders, post-traumatic depression psychological distress drinking behavior substance-related disorders